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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04849078
Other study ID # REC/00958 Sidra Ali Naqvi
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date December 30, 2022

Study information

Verified date March 2022
Source Riphah International University
Contact Imran Amjad, PhD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the present study is to translate the Dizziness Handicap Inventory Scale into Urdu, Pashto, Punjabi, Sindhi and Balochi languages. Along with validation of the translated versions by evaluating their validity and reliability in the people of Pakistan, speaking respective languages and suffering from vertigo and dizziness. No such study has been previously conducted in the Pakistan region which translates the scale and follows the proper cross-culture adaptation.


Description:

Dizziness is one of the most common symptoms of many diseases that not only affects the daily activities of the patient but also negatively alters their jobs and functions. Moreover, mostly the patients having dizziness due to vestibular causes are known to face more problems as compared to the others. A precisely valid and reliable tool has been already designed for the measurement of dizziness while keeping the common complaints of patients in mind. The dizziness handicap inventory (DHI) was introduced in 1990 by Jacobson and Newman. The mentioned questionnaire comprises 25 questions that categorize the dizziness effects in three main areas namely; functional (9 questions, 36 points), emotional (9 questions, 36 points) and physical (7 questions, 28 points). The maximum score is 100 and the minimum is 0. The higher the score, the greater handicap is considered. It has high internal consistency. This tool is widely used in clinical setups to evaluate the condition of the patients and determine the levels to which their quality of life has been affected by dizziness. Additionally, it is very easy to be filled and hardly takes 10 minutes at maximum. The DHI is highly compatible with the international classification of functioning, disability and health tool, which was standardized by WHO in 2001 for measuring the effects of various diseases. The aim of DHI is to evaluate the self-perceived handicap effects of dizziness. The target population are the patients suffering from dizziness due to brain injuries, multiple sclerosis and vestibular disorders. Since 1990, the DHI has been translated into various languages in order to make its application better. Some examples of the translated languages include Arabic, Brazilian, Spanish, Chinese, Italian, Dutch, French, Norwegian, and German. All of these translated versions have been proved to be very useful, with high validity, reliability and internal consistency. Thus, The DHI is considered the most beneficial questionnaire for the evaluation of dizziness and unsteadiness, especially related to vestibular rehabilitation. However, this questionnaire does not have any versions that can be utilized in Pakistan such as Urdu, Pushto, Punjabi, Sindhi and Balochi. The purpose of this study is to translate the DHI into Urdu, Pushto, Punjabi, Sindhi and Balochi languages and then evaluating the validity and reliability of these versions in order to make this questionnaire available for research and clinics for the population of Pakistan.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The patient suffering from vertigo and dizziness for at least 1 month and - The ability to walk independently or do their routine tasks will be included in the study. - Patients should be capable to complete the questionnaire without any help. Exclusion Criteria: - Patients suffering from blindness, - musculoskeletal abnormalities, - neurologic disorder, or paralysis in ENT or neurologic evaluation by ENT and - neurologist will be excluded from the study. - Also, if the patients are unable to cooperate then, they will also be excluded.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Riphah International University Islamabad Fedral

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

Alsanosi AA. Adaptation of the dizziness handicap inventory for use in the Arab population. Neurosciences (Riyadh). 2012 Apr;17(2):139-44. — View Citation

Castro AS, Gazzola JM, Natour J, Ganança FF. [Brazilian version of the dizziness handicap inventory]. Pro Fono. 2007 Jan-Apr;19(1):97-104. Portuguese. — View Citation

Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. — View Citation

Kurre A, Bastiaenen CH, van Gool CJ, Gloor-Juzi T, de Bruin ED, Straumann D. Exploratory factor analysis of the Dizziness Handicap Inventory (German version). BMC Ear Nose Throat Disord. 2010 Mar 15;10:3. doi: 10.1186/1472-6815-10-3. — View Citation

Kurre A, van Gool CJ, Bastiaenen CH, Gloor-Juzi T, Straumann D, de Bruin ED. Translation, cross-cultural adaptation and reliability of the german version of the dizziness handicap inventory. Otol Neurotol. 2009 Apr;30(3):359-67. doi: 10.1097/MAO.0b013e3181977e09. — View Citation

Nola G, Mostardini C, Salvi C, Ercolani AP, Ralli G. Validity of Italian adaptation of the Dizziness Handicap Inventory (DHI) and evaluation of the quality of life in patients with acute dizziness. Acta Otorhinolaryngol Ital. 2010 Aug;30(4):190. — View Citation

Nyabenda A, Briart C, Deggouj N, Gersdorff M. [Normative study and reliability of French version of the dizziness handicap inventory]. Ann Readapt Med Phys. 2004 Apr;47(3):105-13. French. — View Citation

Pérez N, Garmendia I, Martín E, García-Tapia R. [Cultural adaptation of 2 questionnaires for health measurement in patients with vertigo]. Acta Otorrinolaringol Esp. 2000 Oct;51(7):572-80. Spanish. — View Citation

Poon DM, Chow LC, Au DK, Hui Y, Leung MC. Translation of the dizziness handicap inventory into Chinese, validation of it, and evaluation of the quality of life of patients with chronic dizziness. Ann Otol Rhinol Laryngol. 2004 Dec;113(12):1006-11. — View Citation

Tamber AL, Wilhelmsen KT, Strand LI. Measurement properties of the Dizziness Handicap Inventory by cross-sectional and longitudinal designs. Health Qual Life Outcomes. 2009 Dec 21;7:101. doi: 10.1186/1477-7525-7-101. — View Citation

Vereeck L, Truijen S, Wuyts F, Van de Heyning PH. Test-retest reliability of the Dutch version of the Dizziness Handicap Inventory. B-ENT. 2006;2(2):75-80. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Cross-Cultural Translation of Dizziness Handicap Inventory Scale into the local languages (Punjabi, Pashto, Sindhi, Balochi and Urdu) The Dizziness Handicap Inventory Scale is a first-hand measure of disability for patients with vertigo and dizziness. The mentioned questionnaire comprises 25 questions that categorize the dizziness effects in three main areas namely; functional (9 questions, 36 points), emotional (9 questions, 36 points) and physical (7 questions, 28 points). The maximum score is 100 and the minimum is 0. The higher the score, the greater handicap is considered. It distinguishes itself from other published scales as it has an approach that deals with the concepts of disability and its assessment. Its translation is to be done in the local languages of Pakistan through a rigorous and approved process. 6 months
Secondary Reliability of translated versions To determine the reliability of cross-culturally adapted and the translated Dizziness Handicap Inventory versions in patients with vertigo and dizziness of respective languages? Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two or more interval between different visits of the patient. Thus this will be measured through test re-test reliability. 6 months
Secondary Validity of translated versions To determine the validity of cross-culturally adapted and the translated Dizziness Handicap Inventory versions in patients with vertigo and dizziness of respective languages? Validity is how accurate the results are. Thus this will be measured through various parameters to validate the translated versions as appropriate and applicable. 6 months
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